Rituximab for HTLV-1-associated Myelopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-15

Study Completion Date

2024-07-31

Brief Summary

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Neuroprotective or anti-inflammatory strategies are invaluable in HTLV-1-associated myelopathy due to its rapid progression. We evaluated the efficacy of rituximab in patients with HTLV-1-associated myelopathy.

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Detailed Description

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Conditions

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HTLV-1-associated Myelopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Experimental: Rituximab group Drug: Rituximab will be administered as 100 mg IV, once per week for 3 consecutive weeks. Continued dosage was dependent on the percentage of circulating CD19 B-cell counts from patients . Whenever it reached 1% of total lymphocyte population, rituximab 100 mg was reinfused

Placebo Comparator: Control group Patients will receive usual care and drug use.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rituximab group

Rituximab will be administered as 100 mg IV, once per week for 3 consecutive weeks. Continued dosage was dependent on the percentage of circulating CD19 B-cell counts from patients . Whenever it reached 1% of total lymphocyte population, rituximab 100 mg was reinfused

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

A lower dosage of rituximab for HTLV-1-associated myelopathy

Control group

Patients will receive usual care and drug use.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rituximab

A lower dosage of rituximab for HTLV-1-associated myelopathy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18-80 years
* Patients HTLV-1-associated myelopathy (tropical spastic paraparesis)

Exclusion Criteria

* Anticipated survival of at least 3 years
* Inability to undergo neuroimaging with Magnetic Resonance
* Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs \>2x normal, coagulopathy as described)
* Comorbid conditions likely to complicate therapy including but not limited to the following: a history of New York Heart Association class II, III, or IV Congestive Heart Failure; end-stage acquired immune deficiency syndrome
* Pregnancy
* Malignancy (history of or active)
* Concomitant use with antineoplastic, immunosuppressive or immune modulating therapies

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No